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Heart drug mavacamten tested for long-term safety in HCM patients

NCT ID NCT03723655

Disease control Sponsor: Bristol-Myers Squibb Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at the long-term safety of the drug mavacamten in adults with hypertrophic cardiomyopathy, a condition where the heart muscle thickens. About 314 people who had already finished earlier studies took part. The goal was to track side effects over time, not to cure the disease.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

314 people

The number who actually took part.

Started

Sep 2018

Finished

Jan 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: * Has completed the Parent Study through to the EOS Visit within 90 days of consent. (Participants who are beyond the 90-day window from EOS Visit may be included in this study pending MyoKardia Medical Monitoring approval) Participants who prematurely discontinued from the Parent Study or the MAVA-LTE study may be considered for inclusion. * Has a body weight greater than 45 kg at the Screening Visit * Has adequate acoustic windows to enable accurate TTEs. * Has documented LVEF ≥ 50% by echocardiography core laboratory read of screening TTE at rest. * Has safety laboratory parameters (chemistry, hematology, coagulation, and urinalysis) within normal limits (according to the central laboratory reference range). * Female participants must not be pregnant or lactating and, if sexually active, must use one of the following highly effective birth control methods from the Screening Visit through 90 days after the last dose of investigational medicinal product (IMP). In addition to the above contraceptive requirements for female participants, male partners must also use a contraceptive (eg. barrier, condom, or vasectomy). Key Exclusion Criteria: * Has any ECG abnormality considered by the investigator to pose a risk to participant safety (eg. second degree atrioventricular block type II). * Has a history of syncope or a history of sustained ventricular tachyarrhythmia with exercise between Parent Study EOS Visit and Screening Visit. * Has a history of resuscitated sudden cardiac arrest or known history of appropriate implantable cardioverter-defibrillator (ICD) discharge for life-threatening ventricular arrhythmia between Parent Study EOS Visit and Screening Visit. (Note: history of anti-tachycardia pacing (ATP) is allowed).• Currently treated with disopyramide or ranolazine (within 14 days prior to Screening) or treatment with disopyramide or ranolazine is planned during the study. * Has any acute or serious comorbid condition (eg. major infection or hematologic, renal, metabolic, gastrointestinal, or endocrine dysfunction) that, in the judgment of the Investigator, could lead to premature termination of study participation or interfere with the measurement or interpretation of the efficacy and safety assessments in the study. * History of clinically significant malignant disease that developed since enrollment in the Parent Study. * Is unable to comply with the study requirements, including the number of required visits to the clinical site. * Has participated in a clinical trial in which the participant received any investigational drug (or is currently using an investigational device) within 30 days prior to Screening, or at least 5 times the respective elimination half-life (whichever is longer), except for participation in MAVERICK-HCM or EXPLORER-HCM. Prior participation in a non-interventional observational study is allowed.

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Conditions

The condition(s) this trial relates to.

hypertrophic cardiomyopathy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hypertrophic cardiomyopathy Non-obstructive hypertrophic cardiomyopathy Obstructive hypertrophic cardiomyopathy

Contacts and locations

Locations

  • Local Institution - 0001

    Brussels, 1070, Belgium

  • Local Institution - 0002

    Aalst, 9300, Belgium

  • Local Institution - 0003

    Edegem, 2650, Belgium

  • Local Institution - 0009

    Prague, 140 21, Czechia

  • Local Institution - 0010

    Prague, 128 08, Czechia

  • Local Institution - 0011

    Aarhus, 8000, Denmark

  • Local Institution - 0012

    Frederiksberg, 2000, Denmark

  • Local Institution - 0013

    Odense, 5000, Denmark

  • Local Institution - 0014

    Nantes, 44093, France

  • Local Institution - 0015

    Toulouse, 31059, France

  • Local Institution - 0016

    Paris, 75015, France

  • Local Institution - 0017

    Paris, 75013, France

  • Local Institution - 0018

    Dresden, 01277, Germany

  • Local Institution - 0019

    Göttingen, 37075, Germany

  • Local Institution - 0020

    Bad Nauheim, 61231, Germany

  • Local Institution - 0021

    Heidelberg, 69120, Germany

  • Local Institution - 0022

    Ramat Gan, 52621, Israel

  • Local Institution - 0023

    Safed, 13100, Israel

  • Local Institution - 0024

    Petah Tikva, 4941492, Israel

  • Local Institution - 0025

    Rehovot, 76100, Israel

  • Local Institution - 0026

    Tel Aviv, 6423906, Israel

  • Local Institution - 0027

    Jerusalem, 9112001, Israel

  • Local Institution - 0028

    Florence, 50139, Italy

  • Local Institution - 0029

    Maastricht, 6229 HX, Netherlands

  • Local Institution - 0030

    Rotterdam, 3015 CE, Netherlands

  • Local Institution - 0031

    Poznan, 61-848, Poland

  • Local Institution - 0032

    Warsaw, 04-628, Poland

  • Local Institution - 0033

    Katowice, 40-555, Poland

  • Local Institution - 0034

    Krakow, 31-501, Poland

  • Local Institution - 0035

    Lisbon, 1500-650, Portugal

  • Local Institution - 0036

    Almada, 2805-267, Portugal

  • Local Institution - 0037

    El Palmar, 30120, Spain

  • Local Institution - 0038

    A Coruña, 15006, Spain

  • Local Institution - 0039

    Majadahonda, 28222, Spain

  • Local Institution - 0040

    Madrid, 28034, Spain

  • Local Institution - 0041

    Seville, 41009, Spain

  • Local Institution - 0042

    London, W1G 8PH, United Kingdom

  • Local Institution - 0043

    New Haven, Connecticut, 06520-8017, United States

  • Local Institution - 0044

    Portland, Oregon, 97239, United States

  • Local Institution - 0045

    Scottsdale, Arizona, 85259, United States

  • Local Institution - 0046

    Philadelphia, Pennsylvania, 19104, United States

  • Local Institution - 0047

    Durham, North Carolina, 27710, United States

  • Local Institution - 0048

    St Louis, Missouri, 63110, United States

  • Local Institution - 0049

    Iowa City, Iowa, 52242, United States

  • Local Institution - 0050

    Chicago, Illinois, 60611, United States

  • Local Institution - 0051

    Ann Arbor, Michigan, 48109, United States

  • Local Institution - 0052

    Cincinnati, Ohio, 45267, United States

  • Local Institution - 0053

    Charlottesville, Virginia, 22903, United States

  • Local Institution - 0054

    Boston, Massachusetts, 02115, United States

  • Local Institution - 0055

    Houston, Texas, 77030, United States

  • Local Institution - 0056

    New York, New York, 10032, United States

  • Local Institution - 0057

    Houston, Texas, 77030, United States

  • Local Institution - 0058

    Los Angeles, California, 90027, United States

  • Local Institution - 0059

    Richmond, Virginia, 23298, United States

  • Local Institution - 0060

    New York, New York, 10016, United States

  • Local Institution - 0061

    Dallas, Texas, 75390, United States

  • Local Institution - 0062

    Salt Lake City, Utah, 84112, United States

  • Local Institution - 0063

    Stanford, California, 94305, United States

  • Local Institution - 0064

    Pittsburgh, Pennsylvania, 15213, United States

  • Local Institution - 0065

    Seattle, Washington, 98195, United States

  • Local Institution - 0066

    San Francisco, California, 94143, United States

  • Local Institution - 0067

    Jacksonville, Florida, 32224, United States

  • Local Institution - 0068

    Bethlehem, Pennsylvania, 18015, United States

  • Local Institution - 0070

    Indianapolis, Indiana, 46260, United States

  • Local Institution - 0071

    Charlotte, North Carolina, 28204, United States

  • Local Institution - 0072

    Murray, Utah, 84107-5701, United States

  • Local Institution - 0073

    Memphis, Tennessee, 38104, United States

  • Local Institution - 0074

    Grand Rapids, Michigan, 49503, United States

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